BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 19664069 · Received July 3, 2024

    Report

    Report Number
    3005180920-2024-00444
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 3, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 JUNE 2024 LOT 2002929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2020. EXPIRATION DATE: 2025-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 3 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED TIBIAL COMPONENT. THE CAUSE OF THE SUBSIDED TIBIAL COMPONENT IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526406 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 2002929 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention